Bipolar DepressionPhase 3NCT01256177

Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

A Phase 3 study testing Quetiapine Fumarate (SEROQUEL) Extended Release in people with Bipolar Depression, run by AstraZeneca at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Depression
What is being tested?: Quetiapine Fumarate (SEROQUEL) Extended Release
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 361 participants
Where: 12 sitesChina
Study dates: Dec 2010to Nov 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures
Male and female patients, aged 18 to 65 years, inclusive.
Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).
Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.
Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator

Who cannot join

Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder
Patients whose Young Mania Rating Scale (YMRS) total score >12 at enrolment and randomisation.
Patients with >8 mood episodes during the past 12 months at enrolment.
Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.
Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence.
Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

China12 sites

Research Site
Baoding
Research Site
Beijing
Research Site
Changsha
Research Site
Guangzhou
Research Site
Hangzhou
Research Site
Kunming
Research Site
Nanjing
Research Site
Shanghai
Research Site
Shanxi
Research Site
Tianjin
Research Site
Wuhan
Research Site
Xi'an

Other trials in China

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

Conditions: Bipolar Depression
Being tested: Quetiapine Fumarate (SEROQUEL) Extended Release, Placebo
Keywords: Bipolar Depression, Mental disease,
Medical subject headings: Bipolar Disorder, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Quetiapine Fumarate (SEROQUEL) Extended ReleaseDrug
Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
PlaceboDrug
Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.

Study groups in NCT01256177
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Quetiapine Fumarate (SEROQUEL) Extended Release
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline
Measured: Baseline to Week 8

Secondary outcomes (8)

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)
Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline
Measured: 8 weeks from baseline
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)
Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12
Measured: After 8 week of start of treatment
Change From Baseline to Each Assessment in MADRS Total Score
MADRS total score range: 0 to 60, the higher the score, the more severe.
Measured: Baseline to Week 8
Change From Baseline to Week 8 in HAM-D Total Scores
HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline
Measured: Baseline to Week 8
Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)
CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease
Measured: Baseline to Week 8
The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved
Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "much" or "Very much" improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved.
Measured: After 8 weeks of start of treatment
Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation
MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline
Measured: Baseline to Week 8
Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)
The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease.
Measured: After 8 weeks of start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Nov 2012

First posted8 Dec 2010 (estimated)
Study startDec 2010
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bipolar DepressionStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256177
Sponsor's protocol ID: D144CC00005
Status last verified: Mar 2016
First submitted: 7 Dec 2010
Last updated: 15 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Li H, Gu N, Zhang H, Wang G, Tan Q, Yang F, Ning Y, Zhang H, Lu Z, Xu X, Shi J, Gao C, Li L, Zhang K, Tian H, Wang X, Li K, Li H, Xu Y, Xie S, Yu X. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2016 Apr;233(7):1289-97. doi: 10.1007/s00213-016-4215-z. Epub 2016 Feb 25.
PubMed 26911380

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
ClinicalTrials.gov ID: NCT01256177
Acronym / sponsor ID: D144CC00005
Conditions: Bipolar Depression
Keywords: Bipolar Depression, Mental disease,
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 3 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Quetiapine Fumarate (SEROQUEL) Extended Release
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of informed consent prior to any study specific procedures
Male and female patients, aged 18 to 65 years, inclusive.
Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).
Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.
Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator

Key exclusion criteria (7 listed)

Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder
Patients whose Young Mania Rating Scale (YMRS) total score >12 at enrolment and randomisation.
Patients with >8 mood episodes during the past 12 months at enrolment.
Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Quetiapine Fumarate (SEROQUEL) Extended ReleaseQuetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.	Drug	1
PlaceboPlacebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.	Drug	2

Primary outcome

Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Baseline to Week 8
MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline

8 secondary outcomes

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)
Time frame: 8 weeks from baseline
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)
Time frame: After 8 week of start of treatment
Change From Baseline to Each Assessment in MADRS Total Score
Time frame: Baseline to Week 8
Change From Baseline to Week 8 in HAM-D Total Scores
Time frame: Baseline to Week 8
Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)
Time frame: Baseline to Week 8
The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved
Time frame: After 8 weeks of start of treatment
Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation
Time frame: Baseline to Week 8
Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)
Time frame: After 8 weeks of start of treatment

Results and safety

Results posted to the registry on 3 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	148	98
Quetiapine XR	148	111

Primary outcome: Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Time frame: Baseline to Week 8. Least squares mean (Standard Error). Unit: Scores on a scale

Measure	Placebo n = 140	Quetiapine XR n = 139
Change from Baseline to End of Study	-15.27 (0.81)	-18.48 (0.78)
Baseline	28.8 (0.45)	28.5 (0.46)

Placebo vs Quetiapine XR: Least Square Mean difference vs Placebo: -3.22 (95% CI -5.39 to -1.04), p = 0.004, Mixed Model Repeated Measures (MMRM)

Population analysed: Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PLACEBO	3 of 147 (2%)	43 of 147 (29.3%)	Not reported
QUETIAPINE XR	0 of 147 (0%)	81 of 147 (55.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26911380Li H, Gu N, Zhang H, Wang G, Tan Q, Yang F, Ning Y, Zhang H, Lu Z, Xu X, Shi J, Gao C, Li L, Zhang K, Tian H, Wang X, Li K, Li H, Xu Y, Xie S, Yu X. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl). 2016 Apr;233(7):1289-97. doi: 10.1007/s00213-016-4215-z. Epub 2016 Feb 25.
D144CC00005\_CSR\_SynopsisLink provided by the sponsor.

Related trials for Bipolar Depression

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuxin Gu Niufan, MD principal investigator

Shanghai Mental Health Center- Peking University sixth Hospital

Dhaval Desai study director

Wilmington, DE - Delaware

Frank Hou study chair

Astrazeneca China

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quetiapine Fumarate (SEROQUEL) Extended Release in people with Bipolar Depression, run by AstraZeneca at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256177, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.